Blog
RSS FeedPosted by Michael Wonder on 28 Jun 2018
Medicines Australia welcomes shortages legislation
28 June 2018 - Medicines Australia welcomes the introduction of the Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018 ...
Posted by Michael Wonder on 27 Jun 2018
Sandoz restrained from selling MabThera biosimilar in Australia
21 June 2018 - Australia's first biosimilar interlocutory injunction. ...
Posted by Michael Wonder on 26 May 2018
Indivior announces regulatory submission to Australia’s Therapeutic Goods Administration for Sublocade (buprenorphine extended-release) injection for the treatment of opioid dependence
25 May 2018 - Indivior today announced that it has filed a regulatory submission with Australia’s TGA for Sublocade (buprenorphine ...
Posted by Michael Wonder on 09 May 2018
Outcomes of the consultation on the draft list of permitted indications
8 May 2018 - On 6 March 2018, the TGA implemented a list of permitted indications for medicines listed under Section ...
Posted by Michael Wonder on 01 May 2018
Opdivo (nivolumab) is the first and only anti-PD-1 therapy approved by TGA for adjuvant treatment of melanoma
30 April 2018 - Opdivo now approved in Australia for nine indications across six cancer areas in under three years. ...
Posted by Michael Wonder on 23 Apr 2018
Celltrion’s Truxima approved in Australia
20 April 2018 - Celltrion said Sunday it has recently won approval from the Australia's Therapeutic Goods Administration for the ...
Posted by Michael Wonder on 17 Apr 2018
ACSS - NCE work-sharing pilot
17 April 2018 - The ACSS Consortium is a collaborative initiative of like-minded, medium-sized regulatory authorities between Australia's Therapeutic Goods Administration, ...
Posted by Michael Wonder on 16 Apr 2018
Provisional approval pathway - first determination decision
16 April 2018 - Olaratumab (Lartruvo) is the first medicine to be granted a provisional approval determination under the new ...
Posted by Michael Wonder on 06 Apr 2018
MorphoSys announces approvals for Tremfya (guselkumab) for the treatment of moderate-to-severe plaque psoriasis in Brazil and Australia
5 April 2018 - MorphoSys announced today that country subsidiaries of its licensee Janssen reported that Tremfya (guselkumab) has been ...
Posted by Michael Wonder on 05 Apr 2018
Specialised Therapeutics initiates early access program for neratinib maleate
5 April 2018 - Specialised Therapeutics today announces the initiation of an early access program for neratinib maleate an extended ...
Posted by Michael Wonder on 03 Apr 2018
Half yearly performance snapshot: July to December 2017
3 April 2018 - The TGA has maintained a high level of activity while also progressing regulatory reforms over the reporting ...
Posted by Michael Wonder on 28 Mar 2018
Mylan and Biocon receive approvals from the European Commission and TGA Australia for Semglee, biosimilar insulin glargine
27 March 2018 - Mylan and Biocon today announced that their co-developed biosimilar insulin glargine Semglee has received marketing authorisation ...
Posted by Michael Wonder on 20 Mar 2018
Provisional approval pathway: prescription medicines
20 March 2018 - As part of the Government's response to the Review of Medicines and Medical Devices Regulation, the TGA ...
Posted by Michael Wonder on 15 Mar 2018
Product withdrawn after overseas reports of inflammatory brain disorders
15 March 2018 - Consumers and health professionals are advised that Biogen Australia, in consultation with the TGA, will withdraw ...
Posted by Michael Wonder on 22 Feb 2018
Biosimilar medicines regulation
22 February 2018 - This guidance assists sponsors of biosimilar medicines to complete an application to register their medicine on the ...